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Active, Not Recruiting

NCT Number: NCT06444152

Prevalence of Epstein-Barr Virus Infection

This will be a cross sectional, pilot study to determine the burden of EBV related lymphomas in this population. Patient information including demographics and HIV status, history of HIV infection, HIV viral load and CD4 counts and ART history will be retrieved from the integrated patient management system (IPMS) Lymph node excision biopsy samples, collected at NHL between 2012 and 2017, from the patient with a diagnosis of lymphoma will be retrieved using IPMS from National Health Laboratory and analyzed by immunohistochemistry.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Lymph Node Excision Biopsy

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Botswana

Gaborone, 267, Botswana

About this study

Lymph node excision biopsy samples,which have been formalin fixed and paraffin embedded, of 50 HIV-infected and 50 HIV-uninfected patients from the patient with a diagnosis of lymphoma, will be retrieved using IPMS from National Health Laboratory. Archived diagnostic biopsy material will be collected from NHL between 2012 and 2017 (5 years). They will be analyzed by immunohistochemistry using LMP-1/EBNA1/ENNA2 staining, either alone or combined which indicates a diagnosis of EBV infection.

We will compute rates of EBV associated lymphomas among HIV infected and HIV uninfected individuals using descriptive statistics. The students t-test will be used for continuous variables while the Pearson's chi squared test (or Fisher's exact test where appropriate) will be used to compare categorical variables. Significance will be assigned for P values of 0.05 or less

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • All available lymph node biopsy samples with a diagnosis of lymphoma and complete data of HIV status, HIV viral load and CD4 counts and ART history will be retrieved from IPMS.

Exclusion criteria

  • Samples with incomplete data

Treatment and study plan

sample analysis

Other

This study is analyzing stored samples

Primary outcomes

  1. Burden of EBV

    Time frame: 12 months

    The prevalence of EBV associated lymphomas among HIV-infected and HIV-uninfected patients in excision biopsy specimens of lymph nodes. This will be a cross sectional, pilot study to determine the burden of EBV related lymphomas in this population.

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Collaborators

  • University of Botswana

Registry information

Official study title

Prevalence of Epstein-Barr Virus Infection in HIV Infected and HIV Uninfected Patients Presenting With Lymphomas in Botswana

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Jun 5, 2024
Registry last updated
Jan 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.